An FDA advisory panel recommended the approval of Novartis’ chronic obstructive pulmonary disease (COPD) drug Indacaterol, but only at the lower of the two doses proposed by Novartis.
The Pulmonary-Allergy Drug Advisory Committee (PADAC) has backed Indacaterol (QAB149) 75 mcg as a once-daily long-term maintenance bronchodilator treatment in patients with COPD, including chronic bronchitis and/or emphysema in a vote of 13 to four in favour of that dose. However, the panel voted 12 to five against recommending approval of 150 mcg of indacaterol for the indication. The PADAC noted that 75 mcg was seen as effective as the 150 mcg dose and the committee endorsed the safety of both doses.
The recommendation by the PADAC followed a request from the FDA to further explore the efficacy and safety of lower doses of Indacaterol, an investigational medicine in the long-acting beta2-agonist class.
The FDA panel reviewed an extensive program of clinical studies in which the efficacy of Indacaterol at 75mcg and 150mcg was studied in a total of 1,282 COPD patients in five key Phase III trials lasting 12-26 weeks. Results showed that both doses of Indacaterol significantly improved lung function compared to placebo. These improvements were seen five minutes after the first dose and lasted for 24 hours.
The clinical trial program supporting the US submission evaluated safety in 4,764 patients who received Indacaterol for at least 12 weeks at doses of 75mcg and greater, with results supporting the safety and tolerability profile of Indacaterol. The most commonly reported adverse events with both the doses were worsening of COPD, nasopharyngitis, cough and headache
The lung drug is already approved in Europe in November 2009 under the trade name Onbrez Breezhaler at 150 and 300 mcg once-daily doses and brought in revenues of $33 million in 2010. Indacaterol will be sold with the trade name Arcapta Neohaler in the USA if approved by the FDA.